Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Emtricitabine
Drug ID BADD_D00766
Description Emtricitabine is a nucleoside reverse transcriptase inhibitor (NRTI) indicated for the treatment of HIV infection in adults[L9019] or combined with [tenofovir alafenamide] for the prevention of HIV-1 infection in high risk adolescents and adults.[L9010] Emtricitabine is a cytidine analogue.[L9019] The drug works by inhibiting HIV reverse transcriptase, preventing transcription of HIV RNA to DNA.[L9019] Emtricitabine was granted FDA approval on 2 July 2003.[L9019]
Indications and Usage Emtricitabine is indicated in combination with other medications for the treatment of HIV-1 infections;[L9019,L9836] treatment of HIV-1 infections in pediatric patients 25-35kg, treatment of HIV-1 infections in adult patients ≥35kg, for pre exposure prophylaxis of HIV-1 in adolescent and adult patients excluding those who have receptive vaginal sex;[L4388,L9010] treatment of HIV-1 infections in pediatric and adult patients ≥17kg, pre exposure prophylaxis in adolescents and adults ≥35kg;[L9833] treatment of HIV-1 in patients ≥12 years and ≥35kg;[L9587] treatment of HIV-1 in patients weighing ≥35kg;[L9839,L9842] treatment of HIV-1 in patients weighing ≥25kg;[L9647,L9845] and treatment of HIV-1 in patients weighing ≥40kg.[L9848]
Marketing Status approved; investigational
ATC Code J05AF09
DrugBank ID DB00879
KEGG ID D01199
MeSH ID D000068679
PubChem ID 60877
TTD Drug ID D0S9SD
NDC Product Code 65015-827; 65862-301; 61958-0601; 70966-0024; 70518-2906; 33342-500; 42385-710; 53104-7637; 65862-305; 65015-883; 72761-008; 49711-1516; 68554-0064; 69037-0003; 69097-642; 65015-838; 61958-0602; 68554-0027; 52696-0008; 59997-0005; 42385-304; 66406-0209; 66721-400
UNII G70B4ETF4S
Synonyms Emtricitabine | Beta-L-2',3'-dideoxy-5-fluoro-3'-thiacytidine | Beta L 2',3' dideoxy 5 fluoro 3' thiacytidine | Coviracil | Emtriva
Chemical Information
Molecular Formula C8H10FN3O3S
CAS Registry Number 143491-57-0
SMILES C1C(OC(S1)CO)N2C=C(C(=NC2=O)N)F
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Nervous system disorder17.02.10.001---
Neuritis17.09.03.001---
Neuropathy peripheral17.09.03.003---
Neutropenia01.02.03.0040.004666%-
Neutrophil count decreased13.01.06.010--
Oligohydramnios18.05.01.0010.001866%-
Opportunistic infection11.01.08.007---
Osteomalacia14.04.04.001; 15.02.03.001; 20.01.01.002---
Osteonecrosis15.02.04.007; 24.04.05.0040.002800%
Otitis media04.05.01.001; 11.01.05.004--
Pain08.01.08.004--
Pancreatitis07.18.01.001--
Pancreatitis acute07.18.01.0020.001866%-
Paraesthesia17.02.06.005; 23.03.03.0940.001866%
Pharyngitis07.05.07.004; 11.01.13.003; 22.07.03.004--
Pleural effusion22.05.02.0020.002800%
Pneumonia11.01.09.003; 22.07.01.003---
Polyuria20.02.03.002---
Premature baby18.04.02.0010.001866%-
Proteinuria20.02.01.0110.003733%
Prurigo23.03.04.017---
Pruritus23.03.12.001--
Pyrexia08.05.02.0030.005599%
Rash23.03.13.001---
Rash macular23.03.13.003---
Rash maculo-papular23.03.13.004--
Rash pustular11.01.12.002; 23.03.10.003--
Rash vesicular23.03.13.009---
Raynaud's phenomenon24.04.03.0030.002800%-
Renal disorder20.01.02.0020.004106%-
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